uDR - The uDR 596i Radiographic system is intended to - UIH TECHNOLOGIES LLC

Duns Number:117116896

Device Description: The uDR 596i Radiographic system is intended to be used by a qualified/trained doctor or t

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More Product Details

Catalog Number

-

Brand Name

uDR

Version/Model Number

uDr 596i

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KPR

Product Code Name

System, X-Ray, Stationary

Device Record Status

Public Device Record Key

b25a18ca-8edd-4473-96c5-ccf11bb3da62

Public Version Date

May 07, 2020

Public Version Number

1

DI Record Publish Date

April 29, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"UIH TECHNOLOGIES LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 9